C12--QASP.docx

D.2 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored?

· How monitoring will take place.

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government's responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a "living document" and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities. The work performed under this contract shall be subject to evaluation by the COR/CO via the QASP.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO:

Contracting Officer’s (CO) Harold L. McQuillia, CO Department of Veterans Affairs Network Contracting Office (NCO) 6 100 Emancipation Drive, Building 27 Hampton, Virginia 23667 Tel: 757-315-3430 Fax 757-728-3132 harold.mcquillia@va.gov

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR:

Contracting Officer’s Representative (COR)

TBD

Department of Veterans Affairs Charles George Veterans Affairs Medical Center 1100 Tunnel Road Asheville, North Carolina 28805 Tel: TBD

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

Program Manager – TBD

4. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION: 100% surveillance Action required via daily reporting. Surveillance results must be able to support action taken by the COR/Contracting Officer when nonperformance or unacceptable performance occurs.

b. PERIODIC/ RANDOM INSPECTION: Inspections scheduled and reported quarterly per COR delegation or as needed.

c. VALIDATED USER/CUSTOMER COMPLAINTS: Customer complaint data will be obtained via Customer feedback and will be compiled weekly and reviewed by Service Chief. Any validated complaints against the Contractor which are not resolved within seven business days will be further investigated.

d. VERIFICATION AND/OR DOCUMENTATION PROVIDED BY CONTRACTOR: Contractor provided documentation will be reviewed via required daily action reporting.

5. INCENTIVE/DISINCENTIVES FOR ACCEPTABLE QUALITY LEVEL (AQL)

The Government shall use favorable contractor performance evaluations as incentives. The Government shall report unfavorable contractor performance as disincentives. Disincentives shall include documentation of any performance issues. If issues are repetitive or consistent, the government shall take further corrective action or begin termination procedures. Incentives and Disincentives shall be based on exceeding, meeting, or not meeting performance standards.

a. Positive and negative performance will be documented locally (contract file) and/or in the appropriate contractor performance assessment reporting system/database.

b. Noncompliance to contract standards will be corrected at no cost to the government. The government reserves the right and may elect to measure/document negative performance through utilization of a performance report and/or a contract discrepancy report.

c. The contractor shall respond in writing to the Contracting Officer Representative (COR) to all notifications of failure to meet acceptable quality levels within 5 days of issuance by the Contracting Officer Representative and/or the Contracting Officer. The contractor's response shall include the corrective action taken to rectify the problem and the proposed measure to preclude the recurrence of the problem.

6. PERFORMANCE STANDARDS (MEASURES)

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. The performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary Matrix is listed below in Table 1. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Table 1-Performance Requirements Summary Matrix Acceptable Quality Level of Performance

The Contractor shall adhere to the Objectives in accordance with (IAW) Performance Work Statement (PWS) Section 1.0 – Section 2.2

Periodic surveillances will be conducted on a scheduled basis (daily, weekly, monthly, quarterly, semi-annual or annually) and may be adjusted, based on quality trends.

Incentive: favorable contractor performance evaluation.

Disincentive:

A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service Two or more issued CDRs may result in reduction of the monthly invoice of 5%.

The Contractor shall adhere to the Requirements IAW PWS Section 3.0 – Section 4.3.

Disincentive:

A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service Failure to provide the acceptable level of service may be grounds to terminate the contract

The Contractor shall adhere to the Management & Supervision of Contractor Personnel IAW PWS Section 5.0 – Section 6.2.

Disincentive:

A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service

The Contractor shall adhere to all General Requirements and Responsibilities IAW PWS Section 7.1 – 9.3.1.

Disincentive:

A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service

The Contractor shall adhere to all COVID-19 Safety Protocols IAW PWS Section 10.0

Disincentive:

A Contract Discrepancy Report (CDR) will be issued on the first instance of failure to provide the acceptable level of service Failure to provide the acceptable level of service may be grounds to terminate the contract

Incentive: favorable contractor performance evaluation

QUALITY ASSESSMENT OF DENTAL LABORATORY PROCEDURES

I. Complete Dentures

Impression Trays

1. Rigid and fabricated from the appropriate material

2. Covers all indicated anatomy

3. Handles do not interfere with border molding movements, formed as prescribed, so as not to displace facial musculature

4. Impression material retentive features included in the tray as prescribed

Record Base

5. Stable and well adapted to the residual ridge

6. Covers all indicated anatomy

7. Is extended to the land area

8. Is adequately thick for rigidity

9. Is smooth and fee of sharp areas

B. Occlusion Rim - Maxillary

1. Is fabricated from the prescribed baseplate wax

2. Is 10mm wide in the posterior sections

3. The posterior sections are placed over the crest of the residual ridges

4. Is straight from the buccal aspect of the record base border to the buccal aspect of the occlusion rim

5. Tapers in width to 3mm in the anterior section

6. Anterior section angles 5 anteriorly from the horizontal

7. Anterior is 22mm long from the extent of the labial flange

8. Posterior is 18mm long from the extent of the buccal flange

9. All wax is smooth, without voids

10. Adheres well to the record base

11. The occlusal plane is flat, generally parallel to the residual ridge

C. Occlusion Rim - Mandibular

1. Is fabricated from the prescribed baseplate wax

2. Is 10mm wide in the posterior sections

3. The posterior sections are placed over the crest of the residual ridges

4. The posterior sections stop at the beginning of the upward incline of the residual ridges

5. Is straight from the buccal aspect of the record base border to the buccal aspect of the occlusion rim

6. Tapers in width to 3mm in the anterior section

7. Anterior section angles 5 degrees anteriorly from the horizontal

8. Anterior is 18mm long from the extent of the labial flange

9. Posterior extends to the top of the retromolar pad

10. All wax is smooth, without voids

11. Adheres well to the record base

12. The occlusal plane is flat, ideally parallel to the residual ridge

D. Wax Trial Dentures - Maxillary

1. The midline of the arranged teeth matches the marked midline of the occlusion rim

2. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

3. The incisal edges of the anterior teeth are placed in the same plane as the incisal surface of the occlusion rim

4. The interdental wax fills the embrasures up to the contact points

5. Adequate interdental wax fills the embrasures to allow for finishing of the acrylic resin

6. A 4mm band of simulated attached gingival is present, elevated to simulate buccal bone

7. The palatal area is 2mm thick

8. A 1mm band of wax is palatal to the posterior teeth to allow for finishing of the acrylic resin

9. Wax does not overlap onto the beginning/palatal of the ridge-lap area of the anterior teeth

10. The opposing occlusion contacts into proper interdigitation at the established vertical dimension of occlusion

E. Wax Trial Dentures - Mandibular

1. The midline of the arranged teeth matches the marked midline of the occlusion rims

2. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

3. The incisal edges of the anterior teeth are placed to develop the horizontal and vertical overlap necessary for the individual clinical requirements

4. The occlusal plane of the mandibular posterior teeth is at the appropriately indicated height of the retromolar pads (1/2 –2/3 up the RMP, 2mm inferior to the highest portion of the RMP)

5. The central grove line of the mandibular posterior teeth is placed over the crest of the residual ridge

6. The number of posterior teeth is in harmony with space available from the distal of the canine to the beginning of the ascending ramus

7. The interdental wax fills the embrasures up to the contact points

8. Adequate interdental wax fills the embrasures to allow for finishing of the acrylic resin

9. A 4mm band of simulated attached gingival is present, elevated to simulate buccal bone

10. A 1mm band of wax is lingual to the posterior teeth to allow for finishing of the acrylic resin

11. Wax does not overlap onto the beginning lingual of the ridge-lap area of the anterior teeth

12. The buccal shelf area is concave, of adequate thickness

Processed and Polished Prosthesis

13. The acrylic resin is free of pits, fissures, and porosity

14. The acrylic resin is polished on all non-tissue bearing areas

15. The denture borders are anatomically complete

16. No evidence of flash remains on the denture borders

17. The denture bases remain adequately thick for rigidity

II. Removable Partial Dentures

Custom Impression Trays

1. Rigid and fabricated from the appropriate material

2. Covers all indicated anatomy

3. Handles do not interfere with border molding movements, formed as prescribed

4. Impression material retentive features included in the tray as prescribed

Wax Trial Removable Partial Dentures - Maxillary

5. The midline of the arranged teeth matches the marked midline of the occlusion rims

6. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

7. The incisal edges of the anterior teeth are placed in the same plane as the incisal surface of the occlusion rim

8. The interdental wax fills the embrasure up to the contact points

9. Adequate interdental wax fills the embrasure to allow for finishing of the acrylic resin

10. A 4mm band of simulated attached gingival is present, elevated to simulate buccal bone

11. A 1mm band of wax is lingual to the posterior teeth to allow for finishing of the acrylic resin

12. Wax does not overlap onto the beginning/lingual of the ridge-lap area of the anterior teeth

Wax Trial Removable Partial Dentures - Mandibular

1. The midline of the arranged teeth matches the marked midline of the occlusion rims

2. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

3. The incisal edges of the anterior teeth are placed in the same plane as the incisal surface of the occlusion rim

4. The occlusal plane of the mandibular posterior teeth is at the appropriately indicated height of the retromolar pads (1/2 – 2/3 up the RMP, 2mm inferior to the highest portion of the RMP)

5. The central groove line of the mandibular posterior teeth is placed over the crest of the residual ridge

6. The number of posterior teeth is in harmony with space available from the distal of the canine to the beginning of the ascending ramus

7. The interdental wax fills the embrasure up to the contact points

8. Adequate interdental wax fills the embrasure to allow for finishing of the acrylic resin

9. A 4mm band of simulated attached gingival is present, elevated to simulate buccal bone

10. A 1mm band of wax is lingual to the posterior teeth to allow for finishing of the acrylic resin

11. Wax does not overlap onto the beginning/lingual of the ridge-lap area of the anterior teeth

12. The buccal shelf area is concave, of adequate thickness

D. Surveyed Crowns for Removable Partial Denture Abutment

1. All aspects of FPD/crown fabrication are employed

2. Posterior occlusal rests:

III. Fixed Partial Dentures (FPD) Crown

Custom Trays

1. Indicated relief has been well adapted

2. Is well adapted to the teeth and residual ridge

3. Covers all indicated anatomy

4. Completely fills the vestibule when indicated

5. Is extended to the beginning of the land area when indicated

6. Is adequately for rigid

7. Is smooth and free of sharp areas

Working Casts/Dies

8. All necessary anatomic landmarks are included

9. Dies are stable, retentive, and do not rotate

10. No bubbles or defects present in the cast

11. Dies are properly sectioned retaining as much root structure as possible if they will be sent to doctor to be ditched.

Cut-Back Design for Veneer Application

12. Coping/wax crown cut-back design allows for a uniform 2mm thickness of veneer

13. Proximal cut-back design allows for marginal ridge veneer support

14. Rigid connector size is maximized, within the constraints for periodontal health and esthetics

15. A uniform transition exists between metal and veneer material

Veneer Application

16. Axial contours are within normal limits for the particular tooth and/or arch form

17. Applied veneer shade matches the requested shade per shade guide submitted or universal (Vita, Trubyte, Ivoclar, etc.) system

Finish/Polish of FPD/Crown

18. Axial contours are within normal limits for the particular tooth and/or arch form

19. A uniform transition exists between metal and veneer material

20. No unsupported veneer material remains on the alloy substructure

21. All margins are closed on the die

22. The established vertical dimension of occlusion is maintained when the FPD/crown is articulated

23. The veneer material is appropriately finished (glazed, polished, etc.)

24. The substructure metal is highly polished

7. CONTRACT PERFORMANCE MONITORING

Government personnel will monitor the contractor's performance to ensure contract compliance and that the VA is receiving the services. The government will be monitoring the following items:

a. CONTRACTOR PERFOMRANCE – Contractor shall uphold all standards and requirements as stated in the PWS.

b. CUSTOMER SATISFACTION – The Contractor shall provide satisfactory customer service with no customer complaints.

c. INVOICE VERIFICATION RECORDS – The Contractor must provide a complete and accurate invoice each month.

d. QUALITY ASSESSMENT OF DENTAL LABORATORY PROCEDURES - The Contractor shall meet all requirements listed under the Quality Assessment of Dental Laboratory Procedures.

8. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Positive outcome: 98% or greater successful completion/outcome.

Acceptable outcome: 97%-95% Successful completion/outcome.

Unacceptable outcome: Less than 95% successful completion/outcome.

9. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall inform the Contracting Officer (CO). This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR and the CO shall document the discussion and place it in their respective file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the CO. The CO will in turn review and submit to the contractor's program manager for corrective action.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample CDR below.

NETWORK CONTRACTING OFFICE (NCO) 6

CONTRACT DISCREPANCY REPORT

1. CONTRACT NUMBER

DATES

4. DISCREPANCY OR PROBLEM (Describe in detail; Include reference in PWS / Directive. Attach continuation sheet if necessary.)

5. SIGNATURE OF CONTRACTING OFFICER’S REPRESENTATIVE (COR)

8. CONTRACTOR RESPONSE AS TO CAUSE, CORRECTIVE ACTION, AND ACTIONS TO PREVENT RECURRENCE (Attach continuation sheet if necessary.)

11. GOVERNMENT EVALUATION OF CONTRACTOR RESPONSE/RESOLUTION PLAN (Acceptable response/plan, partial acceptance of response/plan, rejection. Attach continuation sheet if necessary)

12. GOVERNMENT ACTIONS (Payment withholding, cure notice, show cause, other.)

CLOSE OUT

CONTRACTOR NOTIFIED

COR

CONTRACTING OFFICER

10. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall communicate with the Contractor and will provide written reports to the Contracting Officer quarterly (or as outlined in the contract or COR delegation) to review Contractor performance.

REVISIONS TO QASP: revisions to the surveillance plan are the joint responsibility of the COR and the Contracting Officer.

11. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

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